Phase 2
Completed N=100
A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section)
Source: ClinicalTrials.gov NCT01198691 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Post Operative Pain — 2.56; 2.90 units on a scale
Summary
The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Operative Pain |
2.56; 2.90 | — |
| PRIMARY Post Operative Pain (3 Days Post-op) |
2.66; 3.52 | — |
| SECONDARY Patient Satisfaction |
20; 21 | — |
Eligibility Criteria
Inclusion Criteria
- Obstetric service patients (receiving prenatal care from the Faculty Medical Center)
- Women greater than 18 years old
- Singleton gestation
- Cesarean Section performed by Pfannenstiel skin incision
Exclusion Criteria
- History of drug or alcohol abuse
- Contraindication to post operative NSAID's or Narcotics
- Emergent Cesarean Deliveries
- Less then 18 years of age
Data sourced from ClinicalTrials.gov (NCT01198691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.